SuspendedNot Applicable

Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System

Stopped: Subject recruitment is temporarily on hold due to ongoing device modification.

United States399 participantsStarted 2020-03-31

Plain-language summary

This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS).

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
✕. Technical obstacles which pose an inordinately high surgical risk
✕. Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella 5.0 or 5.5
✕. Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and elevated LDH equal or greater than 600 IU/L.
✕. Positive pregnancy test if of childbearing potential
✕. Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis
✕. History of any organ transplant
✕. Platelet count \<100,000/mL

What they're measuring

Short-Term Primary Endpoint

Timeframe: 6 months

Long-Term Primary Endpoint

Timeframe: 24 months

Trial details

NCT IDNCT01187368

SponsorEvaheart, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-31

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